2012-09-12 21:56:20 -
Findings Published in The Journal of the American College of Cardiology Suggest
Renal Denervation Could Substantially Reduce Cardiovascular Morbidity and
Mortality for Patients with a Condition that Affects 120 Million People
MINNEAPOLIS - September 12, 2012 - Medtronic, Inc. (NYSE: MDT) today announced
findings from a health-economic analysis published online before print in The
Journal of the American College of Cardiology that suggest the Symplicity(TM)
renal denervation system is a cost-effective treatment strategy for patients
with treatment-resistant hypertension. The Markov model used for this analysis
estimated the discounted incremental cost-effectiveness ratio (ICER) of renal
denervation with the Symplicity system in U.S. dollars per quality-adjusted life
year (QALY) was $3,071 - well below the recognized threshold of $50,000/QALY.
The Symplicity system is available in the
United States for investigational use
The model also projected that, over 10 years, renal denervation plus Standard of
Care (SoC), treatment with three or more anti-hypertensive medications, could
reduce cardiovascular mortality by 30 percent and all-cause mortality by 15
percent compared to SoC alone. Renal denervation with the Symplicity system was
projected to substantially reduce 10-year and lifetime probabilities of stroke,
myocardial infarction (MI), coronary heart disease (CHD), heart failure and end-
stage renal disease (ESRD).
"These results suggest that renal denervation with the Symplicity system is a
cost-effective treatment strategy for resistant hypertension at a value
substantially lower than the commonly accepted threshold," said Brent Egan, M.D.
study co-author, professor, department of medicine, Medical University of
Southern Carolina (MUSC). "Moreover, this health-economic model indicates that
renal denervation with the Symplicity system may decrease mortality and reduce
cardiovascular events in treatment-resistant patients, which would offer a major
advancement in our approach to addressing this growing and costly disease."
The model also found that median survival rates were estimated as 18.4 years for
renal denervation with the Symplicity system compared to 17.1 years for SoC, and
that cardiovascular end points might decrease by 21 percent to 32 percent over
Renal denervation therapy is a minimally invasive, catheter-based procedure that
modulates the output of nerves that lie within the renal artery wall and lead
into and out of the kidneys. These nerves are part of the sympathetic nervous
system, which affects the major organs that are responsible for regulating blood
pressure: the brain, the heart, the kidneys and the blood vessels.
The Markov model used for this analysis was designed by Wing Tech Inc. - based
on risk equations and cost data from the published literature - to project the
economic and clinical impact of renal denervation with the Symplicity system on
patients with treatment-resistant hypertension. Treatment was defined as SoC
plus catheter-based renal denervation with the Symplicity system. The estimated
decrease in systolic blood pressure following renal denervation and other
baseline patient characteristics were based on results of the Symplicity HTN-2
trial published in The Lancet in 2010.
The characteristics of patients enrolled in the HTN-2 trial were mostly similar
to the characteristics reported in other recent studies and registries of
resistant hypertensives ,,, except for systolic blood pressure, as
participants in Symplicity HTN-2 had to have a baseline systolic blood pressure
of ³160 mm Hg per inclusion criteria. All other input parameters used in the
model were derived from systematic searches of the literature. Cardiovascular
event probabilities were obtained from the Framingham risk equations, except for
the incidence of myocardial infarction for which the Prospective Cardiovascular
Münster Heart Study (PROCAM) risk equation was used. End-stage renal disease
incidence was estimated from the results of a more recent cohort study.
Mortality rates were based on the most recent published estimates.
"Our reliance on widely established multivariate risk equations, such as those
from the Framingham heart study, allowed us to comprehensively assess and
confirm the robustness of the model's projections across a wide range of
cardiovascular risk profiles," said Jan B. Pietzsch, Ph.D., senior author and
study director, president and CEO, Wing Tech Inc.
Hypertension is the most common risk factor for the development of
cardiovascular disease and leads to long-term cardiovascular and renal
consequences that place a substantial burden on the health care system.
Research suggests that nearly 30 percent of treated, uncontrolled hypertensive
individuals are considered resistant to treatment, defined as having
persistently high blood pressure despite three or more anti-hypertensive
medications of different types. Treatment-resistant hypertension affects
approximately 120 million people worldwide and is directly associated with
increased risks of heart attacks, stroke, heart failure, kidney disease and
death.(6,) These patients have a substantially increased risk
ofcardiovascular events compared to individuals with controlled high blood
"As our clinical trial program and this cost-effectiveness analysis indicate,
renal denervation with the Symplicity system represents an opportunity for
Medtronic to help millions of patients worldwide while providing cost-effective
solutions to our customers and healthcare systems," said Sean Salmon, Senior
Vice President and President, Coronary & Renal Denervation, Medtronic. "We will
continue to strengthen our leadership position in renal denervation therapy with
additional research, including similar economic and clinical analyses in
ABOUT THE SYMPLICITY(TM)RENAL DENERVATION SYSTEM
The Symplicity((TM)) renal denervation systemwas launched commercially in April
2010 and is currently available in parts of Europe, Asia, Africa, Australia and
the Americas. The Symplicity renal denervation systemhas been successfully used
for nearly five years to treat more than 5,000 patients with treatment-resistant
hypertension worldwide. The Symplicity renal denervation system is not approved
by the U.S. Food and Drug Administration (FDA) for commercial distribution in
the United States.
The Symplicity renal denervation system consists of a flexible catheter and
proprietary generator. In an endovascular procedure, similar to an angioplasty,
the physician inserts the small, flexible Symplicity((TM)) catheter into the
femoral artery in the upper thigh and threads it into the renal artery. Once
the catheter tip is in place within the renal artery, the Symplicity((TM))
generator is activated to deliver a controlled, low-power radio-frequency (RF)
energy routine according to a proprietary algorithm, or pattern, aiming to
deactivate the surrounding renal nerves. This, in turn, reduces hyper-
activation of the sympathetic nervous system, which is an established
contributor to chronic hypertension. The procedure does not involve a permanent
The FDA granted Medtronic approval to conduct the Symplicity HTN-3 study, the
company's U.S. clinical trial of the Symplicity renal denervation system for
treatment resistant hypertension, in August 2011. Symplicity HTN-3 is a
randomized controlled trial designed to evaluate the safety and effectiveness of
renal denervation with the Symplicity renal denervation system in patients with
treatment-resistant hypertension. The study will include approximately 530
treatment-resistant hypertension patients across up to 90 U.S. medical centers.
More information about Symplicity HTN-3 can be found at www.symplifybptrial.com.
In collaboration with leading clinicians, researchers and scientists worldwide,
Medtronic offers the broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular disease and cardiac
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health and extending
life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
- end -
 Krum H, Schlaich M, Whitbourn R, et al. Catheter-based renal sympathetic
denervation for resistant hypertension: a multicenter safety and proof-of-
principle cohort study. Lancet. 2010;376:1903-1909.
 de la Sierra A, Segura J, Banegas JR et al. Clinical features of 8295
patients with resistant hypertension classified on the basis of ambulatory blood
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 Bisognano JD, Bakris G, Nadim MK, Sanchez L, Kroon AA, Schafer J, et al.
Baroreflex activation therapy
lowers blood pressure in patients with resistant hypertension: results from the
placebo-controlled rheos pivotal trial. J Am Coll Cardiol. 2011;58(7):765-73.
 Daugherty SL, Powers JD, Magid DJ, Tavel HM, Masoudi FA, Margolis KL, et al.
Incidence and prognosis
of resistant hypertension in hypertensive patients. Circulation.
World Health Organization. World Health Report 2002: Reducing Risks,
Promoting Healthy Life. Geneva, Switzerland.
Egan, Brent M., et al. "Uncontrolled and Apparent Treatment Resistant
Hypertension in the United States, 1988-2008." Circulation 2011;124:1046-1058.
Hypertension and cardiovascular disease. World Heart Federation. 2011.
disease-risk-factors/hypertension/. Accessed March 2, 2012.
Doumas, Michael, et al. "Benefits from Treatment and Control of Patients with
Resistant Hypertension." International Journal of Hypertension 2011 (2011)
Article ID 318549, 8 pages, 2011. doi:10.4061/2011/318549.
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